Oral hygiene products, such as toothpastes, have been in use for many years. Toothpastes generally include an abrasive material which is dispersed in a gel or paste base. Abrasives remove stains and plaque, as well as polish teeth. Common abrasives include calcium phosphates, alumina, calcium carbonate, and silica. Toothpaste must be abrasive enough to remove plaque and stains, but should not be so abrasive as to damage tooth enamel.
Fluoride is typically added to toothpaste in order to reduce tooth decay. In particular, fluoride incorporates itself into tooth enamel to make teeth more resistant to acids produced by plaque bacteria, as well as acids found in fruit juices, soda and certain foods. Indeed, toothpastes containing fluoride hardens tooth enamel to make the entire tooth structure more resistant to decay and promote remineralization, which aids in repairing early decay. In toothpaste, fluoride is commonly found in the form of sodium monofluorophosphate, stannous fluoride, or sodium fluoride. Notably, due to the toxicity of fluoride, the Food and Drug Administration (FDA) regards any toothpaste containing fluoride as a drug. Accordingly, the FDA requires a warning on the label of any toothpaste containing fluoride stating “If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.” Moreover, the American Dental Association (ADA) requires that toothpaste manufacturers include the following language on all ADA-Accepted toothpastes containing fluoride: “Do not swallow. Use only a pea-sized amount for children under six. To prevent swallowing, children under six years of age should be supervised in the use of toothpaste.” Clearly, toothpastes containing fluoride are not intended to, and should not, be swallowed.
Detergents may also be added to toothpastes to aid in cleaning. For example, detergents may be added to create a foaming action. Foam prevents toothpaste from dribbling out one's mouth during brushing. SLS (sodium lauryl sulfate) is a commonly used detergent.
Toothpastes may also include other ingredients such as, for example, humectants to prevent toothpaste from drying out, thickeners and preservatives to prevent the growth of microorganisms, flavoring agents, sweeteners, and coloring agents.
At least some portion of a serving size of toothpaste is swallowed during brushing, even if not intended. The portion of the toothpaste which is swallowed, including any dietary ingredient(s) therein, is digested in the gastrointestinal tract. Known toothpastes which include vitamins and/or minerals, however, fail to provide the vitamins and/or minerals such as, B-complex of vitamins, Vitamin C, and calcium, for example, in an amount sufficient to be considered a “significant source” of the dietary supplement(s) included therein.
The term “dietary supplement” was defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994. In short, a dietary supplement is a product taken orally that contains a dietary ingredient intended to supplement the diet. The dietary ingredients may include, for example, vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. The DSHEA places dietary supplements in a special category under the general umbrella of foods, not drugs. In particular, if a product contains less than 2 percent of the reference daily intake (RDI) of a given dietary supplement, that product is not a “significant source” of that dietary supplement.
Therefore, what is needed on the market today is a toothpaste that provides a significant source of at least one dietary supplement, such as a vitamin and/or a mineral and does not include fluoride. That is, a non-fluoride toothpaste containing more than 2 percent of the reference daily intake (RDI) of a given dietary supplement that is safe to swallow and supplements the diet of a mammal when ingested is needed on the market today. The present invention provides such toothpaste and is further described in the sections below.